FEATURED EDITORIAL
Scientific and regulatory leaders in the Asia-Pacific region met recently for an exchange of strategies to strengthen convergence and technical competence.
- March 2026 — CDMO Opportunities And Threats Report
- The Business Case For Continuous Manufacturing In Biologics
- Forget Tech Transfer. You Need A Cognitive Connection
- Mastering Biotech's Insourcing/Outsourcing Trade-Offs
- In Palm Beach The Focus Is On Biotech (Not President Trump)
- 4 Facility Considerations for API Manufacturing
- From Principles To Practice: Building Quality Into Generative AI-Assisted Pharma Operations
GUEST COLUMNISTS
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March 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
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The Business Case For Continuous Manufacturing In Biologics
The question for leadership is not if continuous manufacturing will transform biologics, but when and how quickly to invest.
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Mastering Biotech's Insourcing/Outsourcing Trade-Offs
Here's a case for the biotech hybrid model, one that relies on a crack team of internal core talent complemented by broad reliance on external vendors.
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From Principles To Practice: Building Quality Into Generative AI-Assisted Pharma Operations
Learn what regulators are already asking about AI, what quality must mean in this new context, and how organizations can begin building the governance infrastructure.
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Quantifying Single-Use Waste Produced During mAb Manufacture
Discover the current scale of plastic single-use technology waste and its projected growth, specifically for the biomanufacturing domain. There is an increasing need for sustainable solutions.
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From QM To QMM For AI-Assisted Pharmaceutical Manufacturing Operations
The FDA’s focus has shifted from tracking quality metrics to promoting quality management maturity. AI/ML is poised to help with efforts, though it introduces additional complexity around data integrity.
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The Systems And Choreography Needed For Grade B ATMP Material Transfer
Traditional material air locks often fail to account for the sheer throughput needed for cell therapy workflows. These design tips help prevent traffic jams.
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Rethinking ATMP Assurance When Sterility Timelines, Reality Misalign
The compendial 14-day sterility testing window exposes product and patient to numerous risks, but settling on a rapid alternative also presents its own set of challenges.
PHARMA OUTSOURCING WHITE PAPERS
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Advancing Chronic Care Through GLP‑1 Innovation
GLP‑1 therapies are changing injectable care and driving rapid progress in delivery and manufacturing. See how patient needs, emerging tech, and regulations are reshaping chronic treatment.
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Handling Protocols: Key Considerations In The Highly Potent API Market
Explore the growing role of highly potent active pharmaceutical ingredients in oncology and Antibody-Drug Conjugates to highlight manufacturing challenges, safety protocols, and opportunities for CDMOs.
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Efficient Late-Stage Development Of Biologics
Reducing biologics manufacturing costs requires strategic late-stage process development, yield optimization, scale-up, and raw material substitution—all while maintaining product quality and regulatory compliance.
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Selecting The Best Deterministic Method For Your CCIT Project
Container Closure Integrity Testing (CCIT) ensures drug sterility, evolving with regulatory updates like USP <1207>. Deterministic methods are preferred over probabilistic ones to maintain product integrity.
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Compound Library Consortium
Explore how a novel approach to enhancing drug discovery efforts can significantly improve the chances of identifying promising drug candidates, ultimately accelerating the path from discovery to development.
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Developing Effective Procedures
Effective procedure development starts with understanding the purpose and should integrate change management, risk management, and knowledge management to ensure a robust quality system.
PHARMA OUTSOURCING APP NOTES & CASE STUDIES
- Evaluation Of Extractables And Physical Compatibility Of The Mobius® ADC Reactor Single-Use Components For ADC Manufacturing
- Developing A Project Management Office (PMO) At A Small Manufacturing Site
- Accelerate LNP Manufacturing With Automated Process Development
- Advancements In GLP-1 Analog Formulation: Overcoming Challenges
- Development Of A Non-Standard Protein Therapeutic
NEWSLETTER ARCHIVE
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ON-DEMAND WEBINARS
- Formulating The Future: A Practical Guide To Nucleic Acid Therapeutics
- HPAPIS Production: "Where Micrograms Matters"
- From Bench To Approval: Smart IVBE Strategies For Complex Drugs
- From Fermentation To Vaccination
- From Clinical To Commercial: Introducing Devices Earlier To Streamline The DDC Journey